LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX

LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX is an FDA 510(k)-cleared medical device (K260770) manufactured by DiaSorin, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 3, 2026. Regulation: 8.